Note: The policies,
guidelines, terms, and conditions stated in this announcement may differ from
those used by the NIH.

Announcement
TypeThis Funding Opportunity
Announcement (FOA) is a new PA.

Program
Announcement (PA) Number: PAR-10-022

Update: The following update relating to this announcement has been issued:

May 30, 2013 (NOT-OD-13-074) -
NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

August 16, 2010 - IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections
must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

September 29, 2010 (NOT-OD-11-007) - NIH to Require Use of Updated Electronic Application Forms in 2011. Adobe B1 forms are required for due dates on or after May 8, 2011.

NOTICE: Applications submitted in response to this Funding
Opportunity Announcement (FOA) for Federal assistance must be submitted
electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the
application guidelines included with this announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission
and applicants are highly encouraged to start the process at least four (4)
weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: November 5, 2009
Opening Date: December 25, 2009 (Earliest date an application may be
submitted to Grants.gov)NOTE: On-time submission
requires that applications be successfully submitted to Grants.gov no later
than 5:00 p.m. local time (of the applicant institution/organization). Application
Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htmPeer Review Date(s): Generally four months after receipt dateEarliest
Anticipated Start Date(s):Generally
four months after peer review dateExpiration Date: (Extended to January 8, 2014 per NOT-HS-13-001), Originally January 8, 2013

Due Dates for E.O. 12372

Not
Applicable

Additional
Overview Content

Executive Summary

Purpose. The purpose of this Funding Opportunity (FOA) is to
support Research Demonstration and Dissemination (R18)
grant applications from organizations that will implement safe practice interventions that demonstrate
evidence of reducing or eliminating medical errors, risks, hazards, and harms
associated with the process of health care. These 24 month
implementation projects will inform AHRQ, providers, patients, payers, policy
makers, and the public about how safe practice interventions can be
successfully implemented in diverse health care settings and lead to safer and
better health care for all Americans. This FOA follows the release of an
earlier FOA in 2005 that resulted in the release of successful implementation
projects and toolkits available to the public. Background information on the
earlier FOA can be found at http://grants1.nih.gov/grants/guide/FOA-files/FOA-HS-05-012.html.
Examples of and Information on projects from the initial Partnerships in
Implementing Patient Safety FOA can be found at http://www.ahrq.gov/qual/pips/.

Mechanism of Support. This
FOA will utilize the AHRQ Research Demonstration and Dissemination Projects
(R18) award
mechanism. The individual
researcher sponsored by each organizational grantee will be solely responsible
for planning, directing, and executing his or her proposed projects.

Funds Available and Anticipated
Number of Awards.Awards issued under this FOA are
contingent upon the availability of funds and the submission of a sufficient
number of meritorious applications. Because the nature and scope of the
proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary. The
total amount awarded and the number of awards will depend upon the number,
quality, duration, and costs of the applications received.

Budget and Project Period. The total costs awarded under this
FOA will not exceed $300,000 annually for the entire 24 month project period.
Any application with a budget that exceeds $300,000 total costs per year will
not be reviewed. The project period for these grants is 24 months. Funding
beyond the first year will be contingent upon a review and acceptance of the
annual progress report by Agency staff.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their institution/organization to develop an application
for support. Individuals from underrepresented racial and ethnic groups as
well as individuals with disabilities are always encouraged to apply for AHRQ
support. The PI should commit at least 1.2 person months (10 percent of level
of effort) to the project.

Number of PDs/PIs: Only one PD/PI
may be designated on the application.

Number of Applications: Applicants
may submit more than one application, provided each application is
scientifically distinct.

Resubmissions: Applicants are
permitted to submit one resubmission application in response to this FOA.

Renewals: Renewal applications are not permitted in response to this
FOA

Application Materials.SeeSection IV.1for application materials.
All applications, including resubmission, revision and renewal, submitted for
due dates January 25, 2010 and beyond, must utilize the current forms and
instructions.

General Information.For
general information on SF424 (R&R) Application and Electronic Submission,
see these Web sites:

The objective of
this FOA is to support health care
institutions in implementing safe practice interventions that demonstrate
evidence of eliminating or reducing medical errors, risks, hazards, and harms
associated with the process of health care.

Each
applicant must select an evidence-based safe practice intervention to implement
in their institution at the time of grant award. Applicant institutions
are expected to (1) have previously completed a risk assessment which documents
the medical errors, risks, hazards, and harms to be addressed by the safe
practice; (2) develop a complete implementation plan for the safe practice
intervention; (3) describe the projected impact of the safe practice
intervention on the process of care; (4) provide an evaluation plan to
determine whether the safe practice intervention is effective as adopted within
the institution; (5) develop an intervention implementation toolkit; and (6)
develop a dissemination plan for making the intervention available to
others. These implementation projects will inform AHRQ, providers,
patients, payers, policy makers, and the public about how safe practice
interventions can be successfully implemented in diverse health care settings
and lead to safer and better health care for all Americans.

The
selection of the safe practice intervention may be drawn from a variety of
sources including: published recommendations of safe practices such as AHRQ’s
Evidence Reports; the National Quality Forum’s (NQF) Safe Practices for Better
Health Care; Joint Commission on Accreditation of Healthcare Organizations (The
Joint Commission) patient safety goals; and ongoing research findings from
patient safety grants and projects funded by AHRQ and others.

This
FOA is focusing on safe practice interventions that do not focus solely on the
use of health information technology (HIT) [e.g., electronic health records,
personal health records, e-mail communication, clinical alerts and reminders,
computerized provider order entry, computerized decision support systems,
hand-held computers, information resources, and electronic monitoring
systems]. For example, a solely HIT intervention would be the development
of a computerized scheduling system to increase use of perioperative
beta-blockers. However, interventions which utilize HIT in a secondary capacity
would be allowable under this FOA. For example, an intervention which
redesigns workflow and staffing to increase perioperative beta-blocker use
which has e-mail reminders as a secondary component would not be considered a
primarily HIT intervention.

AHRQ
encourages implementation projects that focus on diverse settings of care, safe
practices, and patient populations including priority populations.
Projects presented for consideration under this FOA should comply with the
Agency’s policy regarding the inclusion of priority populations (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Further information on the requirements is listed in the special requirements
section of this FOA.

AHRQ
believes that ultimately patient safety is a local issue that must be addressed
by each health care organization at the point of care. By providing
information in the form of the toolkits that are produced from successful
grants, AHRQ wants to help local health care organizations meet the challenge
of implementing safe practice interventions to improve patient safety.

For
purposes of this FOA, a toolkit is defined as a description of the safety
problem to be addressed, the selection of the intervention to be demonstrated
and how it is to be implemented, the results achieved, any tools developed such
as checklists, training models, DVDs, brochures, etc., and a description of
project barriers and facilitators.

AHRQ
encourages projects that focus on safe practice interventions that can be
generalized to other settings of care and for use by those who wish to adapt
and/or adopt the safe practices interventions to improve patient safety.
At the end of the grant period, the intent of this FOA is that awardees will
have developed tools, including a comprehensive implementation toolkit, a
public web site and materials that can be customized for others’ use. The
toolkit should focus on documenting the impact of the safe practice
intervention on patient care and the manner in which barriers to implementation
and adoption were overcome.

This Funding Opportunity Announcement (FOA) will use
the Research
Demonstration and Dissemination (R18) application.
The Project Director/Principal Investigator (PD/PI) will be solely responsible
for planning, directing, and executing the proposed project.

AHRQ is not using the Modular Grant Application and Award
Process.Applications submitted in modular format will not be reviewed.

2.
Funds Available

Because the nature and scope of
the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of AHRQ provide support for this program, awards pursuant
to this funding opportunity are contingent upon the availability of funds and
the submission of a sufficient number of meritorious applications.

The total cost awarded under this FOA will not exceed $300,000 annually for
the entire 24 month project period. Applications may be up to 24 months in
duration with a budget not to exceed $300,000 per year in total costs to the
government. Funding beyond the first year will be contingent upon a review of
the non-competing continuation report by agency staff. Applications with
budgets that exceed the $300,000 total costs per year limit will not be reviewed.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following
organizations/institutions are eligible to apply:

Public or non-profit private institution, such as a
university, college, or a faith-based or community-based organization;

Units of local or State government;

Eligible agencies of the Federal government.

Indian/Native American Tribal Government (Federally
Recognized);

Indian/Native American Tribal Government (Other than
Federally Recognized);

Indian/Native American Tribally Designated
Organizations.

AHRQ’s authorizing legislation does not allow for-profit
organizations to be eligible to lead applications under this research mechanism,
thus for the purpose of this FOA, AHRQ will make grants only to non-profit
organizations. For-profit organizations may participate in projects as
members of consortia or as subcontractors only. Because the purpose of this
program is to improve healthcare in the United States, foreign institutions may
participate in projects as members of consortia or as subcontractors
only. Applications submitted by for-profit organizations or foreign
institutions will be returned without review. Organizations described in
section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not
eligible.

1.B.
Eligible Individuals

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the PD/PI is invited to work
with his/her organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for AHRQ support.

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response
to this FOA.

While there is no cost sharing requirement included in
this FOA, AHRQ welcomes applicant institutions, including any collaborating
institutions, to devote resources to this effort. An indication of
institutional support from the applicant and its collaborators indicates a
greater potential of success and sustainability of the project. Examples of
institutional support would include: donated equipment and space,
institutional-funded staff time and effort, or other resource investments.
Applicant institutions that plan to provide support should indicateinstitutional
support by outlining the specific contributions to the project and providing
assurances that their organization and any collaborators are committed to
providing these funds and resources to the project. This can be included at
the end of the budget justification section of the application, but
institutional support dollars are not to be shown/included in the detailed budget
request.

3. Other-Special Eligibility Criteria

Resubmissions.Applicants
are permitted to submit one resubmission application in response to this FOA.

Renewals. Renewal
applications are not permitted in response to this FOA.

Number of Applications. Applicants may submit more than one application, provided
each application is scientifically distinct. However, AHRQ will not accept
similar grant applications with essentially the same research focus from the
same applicant organization.

Special
Requirements. Because the FOA is intended to support the introduction and
demonstration of safe practices in the delivery of health care, organizational
entities that are not health care provider organizations must have a provider
organization which is actively engaged in the delivery of health care as a
participating partner in the proposed project. For purposes of this FOA,
a health care provider organization is defined as any organization engaged in
the direct delivery of care to patients in any setting including but not
limited to: in-patient, out-patient or ambulatory centers, community
health centers, emergency medical services, laboratories, diagnostic centers,
pharmacies, blood centers, long term care, and/or home care. For
purposes of this FOA, a toolkit is defined as a description of the safety
problem to be addressed, the selection of the intervention to be demonstrated
and how it is to be implemented, the results achieved, any tools developed such
as checklists, training models, DVDs, brochures, etc., and a description of
project barriers and facilitators.

The
applicant must address the following eight project requirements in the
narrative portion of the application. Applications that do not address
all eight project requirements will not be reviewed.

1. The
applicant, or its’ partner, must be a health care provider organization.
The applicant must specify the safe practice to be introduced and justify its
selection as an intervention to eliminate or mitigate the errors, risks, and
hazards identified. The application must provide supporting evidence that
the intervention to be introduced is a safe practice. The safe practice
intervention may not be solely focused on HIT.

2.
Because implementation projects are intended to introduce established or known
safe practices, the safe practice intervention selected must be able to be
implemented at the beginning of the award of the grant.

3.
The applicant must have already completed a risk assessment and be able to
document the medical errors, risks, hazards, and harms that are to be addressed
with the implementation of a specific safe practice. The applicant must
document how the risk and hazards were identified and the priority for the
organization established. The applicant must identify the patient
population impacted by the risks and hazards and outline the expected benefit
from the implementation of the safe practice.

4.
The applicant must provide an implementation plan including a time line for
introducing the safe practice intervention into the health care delivery
process. This plan should include the identification of barriers and
problems to be overcome in introducing the safe practice intervention.
The plan should discuss the costs and benefits to the institutions of implementing
the safe practice intervention

5.
The applicant must be able to anticipate the level of adoption and acceptance
of the safe practice intervention by health care professionals in their
institution. The applicant should describe potential barriers to adoption
and how these barriers can be overcome.

6.
The applicant must describe generally their plans for creating an
implementation toolkit including each of the tools they anticipate will result
from their project and how they plan to package the toolkit. The applicant
should describe the expected impact and generalizability of any tools
developed. The applicant should describe what they plan to include in the
toolkit such as lessons learned, resources used, and other pre-existing tools
used during the implementation process that might facilitate adaptation and/or
adoption of the safe practice intervention.

7.
The applicant must submit an evaluation plan. The plan should focus on
the performance of the implementation of the safe practice intervention.
The applicant should describe how the safe practice intervention and its
outcomes will be evaluated and assessed. In addition, the evaluation plan
should assess the generalizability of the intervention and the resource
implications.

8. The
applicant must submit a dissemination plan. The plan should be developed
to document and assess the impact of the safe practice intervention on the
process of care and the patient population being addressed by the safe practice
within the applicant institution and any partner organizations as
applicable. The dissemination plan should include the
development of a project Web site that meets all the criteria for Section 508
(Rehabilitation Act) accessibility requirements. For assistance with publishing
materials the applicant should refer to the AHRQ Publishing and Communication
guidelines at http://www.ahrq.gov/news/pubcomguide/.

Section IV. Application and Submission Information

To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing the
SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically”
button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. Several of the
steps of the registration process could take four weeks or more. Therefore,
applicants should immediately check with their business official to determine
whether their organization/institution is already registered with both Grants.gov and the Commons.
All registrations must be complete by the submission deadline for the
application to be considered “on-time” (see 3.C.1 for more information about
on-time submission).

A one-time registration is required for
institutions/organizations at both:

The individual(s) designated as PDs/PIs on the application must
be registered also in the NIH eRA Commons. In the case of multiple
PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in
the eRA Commons prior to the submission of the application.

Each PD/PI must hold a PD/PI
account in the Commons. Applicants should not share a Commons account for both
an Authorized Organization Representative/Signing Official (AOR/SO) role and a PD/PI role; however, if they have
both a PD/PI role and an Internet Assisted Review (IAR) role, both roles should
exist under one Commons account.

When multiple PDs/PIs are proposed, all PDs/PIs at the applicant
organization must be affiliated with that organization. PDs/PIs located at
another institution need not be affiliated with the applicant organization, but
must be affiliated with their own organization to be able to access the Commons.

This registration/affiliation must be done by the AOR/SO or
his/her designee who is already registered in the Commons.

Both the PD(s)/PI(s) and AOR/SO need separate accounts
in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not
sequential. Applicants should begin the registration processes for both
Grants.gov and eRA Commons as soon as their organization has obtained a DUNS
number. Only one DUNS number is required and the same DUNS number must be
referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.

Note that if a PD/PI is also an AHRQ peer reviewer
with an Individual DUNS and CCR registration, that particular DUNS number and
CCR registration are for the individual reviewer only. These are different than
any DUNS number and CCR registration used by an applicant organization.
Individual DUNS and CCR registration should be used only for the purposes of
personal reimbursement and should not be used on any grant applications
submitted to the Federal Government.

1.
Request Application Information

Applicants must download the SF424 (R&R)
application forms and the SF424 (R&R) Application Guide for this FOA
through Grants.gov/Apply.

Note: Only the forms package directly
attached to a specific FOA can be used. You will not be able to use any other
SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although
some of the "Attachment" files may be useable for more than one FOA.

Prepare all applications using the SF424 (R&R)
application forms and in accordance with the SF424
(R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to
submitting a complete and accurate application to NIH. Some fields within the
SF424 (R&R) application components, although not marked as mandatory, are
required by NIH (e.g., the “Credential” log-in field of the “Research &
Related Senior/Key Person Profile” component must contain the PD/PI’s assigned
eRA Commons User ID). Agency-specific instructions for such fields are
clearly identified in the Application Guide. For additional information, see
“Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

The SF424 (R&R) application has several
components. Some components are required, others are optional. The forms
package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

When all PDs/PIs are within a single institution,
follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions

When multiple institutions are involved, one
institution must be designated as the prime institution and funding for the
other institution(s) must be requested via a subcontract to be administered by
the prime institution. When submitting a detailed budget, the prime institution
should submit its budget using the Research & Related Budget
component. All other institutions should have their individual budgets
attached separately to the Research & Related Subaward Budget Attachment(s)
Form. See Section 4.8 of the SF424 (R&R) Application Guide for further
instruction regarding the use of the subaward budget form.

In order to expedite the review, applicants are requested
to notify the AHRQReferral Office by email Gerald.Calderone@ahrq.hhs.govwhen the application has been submitted. Please
include the FOA number and title, PD/PI name, and title of the application.

3.C.
Application Processing

3.C.1 Submitting
On-Time

Applications may be
submitted on or after the opening date and must be successfully received
by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the
application due date(s). (See Section IV.3.A. for all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must
meet the following criteria to be considered “on-time”:

All registrations
must be complete prior to the submission deadline

The application
must receive a Grants.gov tracking number and timestamp (or eRA help desk
ticket confirming a system issue preventing submission) by 5:00 p.m. local time
on the submission deadline date.

Any system
identified errors/warnings must be corrected and the submission process
completed within the “error correction window.”

Submission to Grants.gov is not the last step – applicants must follow
their application through to the eRA Commons to check for errors and warnings
and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified
Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond.
As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See
NOT-OD-10-123.

Once an application package has been successfully
submitted through Grants.gov, NIH provides applicants a two day error correction
window to correct any eRA identified errors or warnings before a final
assembled application is created in the eRA Commons. The standard error
correction window is two (2) business days, beginning the day after the
submission deadline and excluding weekends and standard federal holidays. All
errors must be corrected to successfully complete the submission process.
Warnings will not prevent the application from completing the submission
process.

Please note that the following caveats apply:

Initial
application submission must be “on-time.”

The
AOR/institutions is expected to enforce that application changes made within
the error correction window are restricted to those necessary to address
system-identified errors/warnings. NIH may reject any application that
includes additional changes.

Proof of
“on-time” submission (e.g., Grants.gov timestamp and tracking number) and
description of all changes made within the window must be documented in the PHS
398 Cover Letter component of the application.

3.C.3 Viewing an Application in the eRA
Commons

Once any eRA identified errors have been addressed and
the assembled application has been created in the eRA Commons, the PD/PI and the Authorized
Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday
– Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further
processing.

If everything is acceptable, no further action is
necessary. The application will automatically move forward to the
Division of Receipt and Referral in the Center for Scientific Review for
processing after two
weekdays, excluding Federal holidays.

Prior to the submission deadline, the AOR/SO can
“Reject” the assembled application and submit a changed/corrected
application within the two-day viewing window. This option should be used
if it is determined that some part of the application was lost or did not
transfer correctly during the submission process, the AOR/SO will have the
option to “Reject” the application and submit a Changed/Corrected
application. In these cases, please contact the eRA
Help Desk to ensure that the issues are addressed and corrected. Once
rejected, applicants should follow the instructions for correcting errors
in Section 2.12, including the requirement for cover letters on late applications. The “Reject” feature should also be used if you determine that
warnings are applicable to your application and need to be addressed now.
Remember, warnings do not stop further application processing. If an
application submission results in warnings (but no errors), it will
automatically move forward after two weekdays if no action is taken. Some
warnings may need to be addressed later in the process.

If the two-day window falls after
the submission deadline, the AOR/SO will have the option to “Reject” the
application if, due to an eRA Commons or Grants.gov system issue, the
application does not correctly reflect the submitted application package (e.g.,
some part of the application was lost or didn’t transfer correctly during the
submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and
determine the best course of action. NIH will not penalize the applicant for an
eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject”
the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted,
but it will be subject to the NIH late
policy guidelines
and may not be accepted. The reason for this delay should be explained in the
cover letter attachment.

Both the AOR/SO and PD/PI will
receive e-mail notifications when the application is rejected or the
application automatically moves forward in the process after two weekdays.

Upon receipt, applications will be evaluated for completeness by the Center
for Scientific Review, NIH, and AHRQ.
Incomplete applications will not be reviewed.

There will be an
acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives
the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility
of the applicant to check periodically on their application status in the Commons.

AHRQ will not accept any application in response to
this FOA that is essentially the same as one currently pending initial merit
review unless the applicant withdraws the pending application. AHRQ will not
accept any application that is essentially the same as one already reviewed.
However, AHRQ will accept a resubmission application, but such application must
include an Introduction addressing the critique from the previous review.

Although there is no immediate acknowledgement of the
receipt of an application, applicants are generally notified of the review and
funding assignment within eight (8) weeks.

Use of CMS Data

Purchase of Centers for Medicare & Medicaid Services
(CMS) public-use data, if required, should be discussed in the application
narrative and included in the budget. Projects will ordinarily not use CMS
(Medicare or Medicaid) data involving individual identifiers. However, for
applications that propose to use Medicare or Medicaid data that are
individually identifiable, applicants should state explicitly in the “Research
Design and Methods” section of the Research Plan (form 398) the specific files,
time periods, and cohorts proposed for the research. In consultation with
CMS, AHRQ will use this information to develop a cost estimate for obtaining
the data. This estimate will be included in the estimated total cost of
the grant at the time funding decisions are made.

Applicants should be aware that for individually
identifiable Medicare and Medicaid data, Principal Investigators and their
grantee institutions will be required to enter into a Data Use Agreement (DUA)
with CMS to protect the confidentiality of data in accordance with the
confidentiality provision in the AHRQ statute, 42 USC 299c-3(c); the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule at 45
CFR Parts 160 and 164, if applicable; and standards set out in OMB Circular
A-130, Appendix III–Security of Federal Automated Information Systems. The use
of the data will be restricted to the purposes and time period specified in the
DUA. At the end of this time period, the grantee will be required to return the
data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional
arrangements, the DUA will include the requirement that the data user agrees to
submit to CMS, a copy of all findings within 30 days of making such findings,
for the sole purpose of assuring CMS that data confidentiality is maintained.
The user further agrees not to submit these findings to any third party (including
but not limited to any manuscript to be submitted for publication) until
receiving CMS's approval to do so.

In developing research plans, applicants should allow
time for refining, obtaining approval, and processing of their CMS data
requests. Requests may take six months from the time they are submitted to
complete. Applications proposing to contact beneficiaries or their providers
require the approval of the CMS Director and may require meeting(s) with CMS
staff.

CMS data are provided on IBM mainframe tapes using the
record and data formats commonly employed on these computers. Applicants should
either have the capability to process these tapes and formats or plan to make
arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the
AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include
the cost of identifiable CMS data in the budget. In the event the total
costs of the project plus the cost of CMS data is greater than the total cost
cap of this FOA, the budget for the project will be adjusted so that the total
costs awarded to the recipient plus the CMS data costs do not exceed the cost
cap.

For
efficient grant administration, AHRQ grant administration procedures will be
used and conducted in accordance with the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy
Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm

Pre-award costs are allowable. A
grantee may, at its own risk and without AHRQ prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new award if such costs are necessary to conduct the
project and would be allowable under the grant, if awarded, without AHRQ prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain AHRQ approval before incurring the cost. AHRQ prior
approval is required for any costs to be incurred more than 90 days before the
beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on AHRQ either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.

6. Other Submission Requirements

Applications must use the
detailed budget format.

The budget must include
funding to allow the PD/PI and at least one key program staff member of the
project to attend 3 days of an annual AHRQ-sponsored meeting in the Washington, DC area for each year of funding.

The applicant organization
must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions
– Application Guide, Electronic
Submission of Grant Applications.”

PHS398 Research Plan Component Sections

The Research Strategy section
of the R18 application may not exceed 25 pages, including tables,
graphs, figures, diagrams, and charts.

All application instructions
outlined in the SF424 (R&R) Application Guide are to be followed,
incorporating "Just-in-Time" information concepts, and with the
following additional requirements:

Special Instructions for Modular Grant applications

AHRQ is not using the Modular Grant Application and Award
Process. Applicants for funding from AHRQ should ignore application
instructions concerning the Modular Grant Application and Award Process, and
prepare applications using instructions for the Research and Related Budget
Components of the SF 424 (R&R). Applications submitted in the Modular
format will be returned without review.

Do not use the Appendix to
circumvent the page limitations.. An application that does not comply with the
required page limitations may be delayed in the review process.

Priority Populations

The Healthcare Research and Quality Act of 1999, in
amending the Public Health Service Act, directed AHRQ, in carrying out its
mission, to conduct and support research and evaluations, and to support
demonstration projects, with respect to the delivery of health care in
inner-city and rural areas (including frontier areas), and health care for
priority populations. Priority populations include low income groups; minority
groups; women; children; the elderly; and individuals with special health care
needs, including individuals with disabilities and individuals who need chronic
care or end-of-life health care. This authority is found at 42 USC
299(c). To implement this statutory mandate, AHRQ published a Notice in
the NIH Guide on February 28, 2003, establishing a new Agency policy on the
Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).
Applicants under this FOA should consider and discuss including priority
populations in the research design as specified in this Notice.

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the
results of AHRQ-funded research into practice and policy, grantees are to
inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when
articles from their AHRQ-supported activities are accepted for publication in
the professional literature. Grantees also should discuss any ideas about
other dissemination and marketing efforts with OCKT staff. The goal is to
ensure that efforts to disseminate research findings are coordinated with other
Agency activities to maximize awareness and application of the research by potential
users, including clinicians, patients, health care systems and purchasers and
policymakers. This is critical when outreach to the general and trade
press is involved. Accordingly, contact with the media will take place
with close coordination between OCKT and the press offices of the grantee's institutions. In cases when products are created (such as annual or final reports,
Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief
plan describing how the product will be publicized. An OCKT staff person
will be assigned to each product and will coordinate the implementation of the
plan, especially issues related to printing and electronic dissemination, and
outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs,
AHRQ may request information essential to an assessment of the effectiveness of
Agency research programs. Accordingly, grant recipients are hereby
notified that they may be contacted after the completion of awards for periodic
updates on publications resulting from AHRQ grant awards, and other information
helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed
of publications, as well as the known uses and impact of their Agency-sponsored
research. Applicants must agree to notify AHRQ immediately when a manuscript
based on research supported by the grant is accepted for publication, and to
provide the expected date of publication as soon as it is known, regardless of
whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’S
Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel
Survey (MEPS). HCUP is a family of health care databases and related
software tools and products developed through a Federal-State-Industry
partnership. HCUP databases bring together the data collection efforts of
State data organizations, hospital associations, private data organizations,
and the Federal government to create a national information resource of
patient-level health care data. HCUP databases provide data beginning in
1988 and contain encounter-level information for all payers compiled in a
uniform format with privacy protections in place. HCUP includes three
nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids’
Inpatient Database (KID), and the Nationwide Emergency Department Sample
(NEDS), and three types of State databases, the State Inpatient Databases (SID),
the State Ambulatory Surgery Databases (SASD), and the State Emergency
Department Databases (SEDD). More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally
representative estimates of health care use, expenditures, sources of payment,
and insurance coverage for the U.S. civilian, non-institutionalized
population. MEPS is composed of three component surveys: the Household
Component (HC), the Medical Provider Component (MPC), and the Insurance
Component (IC). The Household Component is the core survey, and it
forms the basis for the MPC sample and part of the IC sample. The MEPS IC
collects data on health insurance plans obtained through employers and unions,
including the number and types of private insurance plans offered, employer
characteristics, premiums, and contributions by employers and employees.
More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants’ use of HCUP and/or MEPS data does not
preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data
being collected and how the investigator is planning to share the data.
Applicants who are planning to share data may wish to describe briefly the
expected schedule for data sharing; the format of the final dataset; the
documentation to be provided; whether or not any analytic tools also will be
provided; whether or not a data-sharing agreement will be required and, if so,
a brief description of such an agreement (including the criteria for deciding
who can receive the data and whether or not any conditions will be placed on
their use); and the mode of data sharing (e.g., under its own auspices by
mailing a disk or posting data on its institutional or personal website or
through a data archive or enclave). Investigators choosing to share under their
own auspices may wish to enter into a data-sharing agreement. References to
data sharing may also be appropriate in other sections of the application.

The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.

Section V. Application Review Information

1.
Criteria

Only the review criteria
described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications
that are complete and responsive to the FOA will be evaluated for scientific
and technical merit by an appropriate peer review group convened in accordance
with standard AHRQ peer review procedures that are described in 42 CFR Part 67,
Subpart A. Incomplete and/or non-responsive applications or applications
not following instructions given in this FOA will be returned to the applicant
without further consideration.

As part of the initial merit review, all applications
will:

Undergo a selection process in which only those
applications deemed to have the highest scientific merit will be discussed
and assigned an impact/priority score

Receive a written critique

The mission of the NIH is to support science
in pursuit of knowledge about the biology and behavior of living systems and to
apply that knowledge to extend healthy life and reduce the burdens of illness
and disability. As part of this mission, applications submitted to the
NIH for grants or cooperative agreements to support biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact. Reviewers
will provide an overall impact/priority score to reflect their assessment of
the likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved, in consideration of the following five core review
criteria, and additional review criteria (as applicable for the project
proposed).

Core Review Criteria. Reviewers
will consider each of the five review criteria below in the determination of
scientific and technical merit, and give a separate score for each. An application
does not need to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance.Does the proposed project address an important patient safety
problem? Will the proposed safe practice intervention make a difference
in patient care and improved patient safety? If the aims of the project
are achieved, how do they advance the diffusion and adoption of effective safe
practice interventions into practice? What are the overall benefits to
patients and society of implementing the safe practice intervention? Has the
applicant addressed the eight project requirements?

Investigator(s).What are the qualifications of the PI to lead the implementation
effort for the safe practice intervention? Does the PI provide at least a
10 percent level of effort to the project? What are the qualifications of the
key personnel designated to assist the PI? Has the project included
outside resources or partners that have expertise in implementing safe practice
interventions if they are not present in the organization?

Innovation. Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
develop new methods for implementation? Is the safe practice intervention
one that has not widely been implemented and for which implementation tools are
not already available?

Approach. Does the application adequately demonstrate the completion
of a risk assessment for the safe practice intervention? Is there a clear
plan for implementation including a project management plan, clear objectives,
timelines, and deliverables? Does the project plan have clear and well-reasoned
goals consistent with those stated by AHRQ in this FOA? Does the
application acknowledge potential problem areas and consider alternative
tactics? Are the barriers to adoption and difficulties in implementation
adequately addressed?

Environment. Does the
organizational climate support the improvement of patient safety? Is
there a positive safety culture within the organization which will contribute
to the probability of success? Does the proposed project take advantage
of unique features of the organizational environment or employ useful
collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed,
reviewers will consider the following additional items in the determination
of scientific and technical merit, but will not give separate scores for these
items.

Budget: How reasonable is
proposed project budget and the requested period of support in relation to the
proposed safe practice intervention? Are dedicated grantee resources sufficient
to ensure commitment on the part of key personnel? Is there effective and
efficient use of project resources? Is there specific evidence of the
nature and extent of the applicant institution resource contribution? Does the
budget include support for travel to an AHRQ-sponsored meeting?

Degree
of Responsiveness. How well does the application address the purpose and
objectives of this FOA? Has the applicant addressed all eight project
requirements? Is this application focused on a critical patient safety issue
for their organization? How responsive is the application to the eight
project requirements for partnerships in implementing patient safety?

Evaluation
and Assessment of Impact. Does the application include an evaluation plan for
assessing the implementation of the safe practice intervention and documenting
its impact on the institution and the target patient population at risk?
Does the application include a dissemination plan and an assessment of the
level of adoption and acceptance of the safe practice intervention? What
is the potential of the applicant institution to develop an implementation
toolkit on the safe practice interventions and share this toolkit with AHRQ for
dissemination?

Generalizability. How generalizable
would the safe practice intervention be to other settings of care and other
institutions? Can the implementation toolkit for the safe practice
intervention resulting from the project be adapted and/or adopted by other
parts of the applicant institutions and other institutions? How
generalizable would the proposed project findings and tools be to other
institutions implementing patient safety improvements?

Institutional
Support and Commitment. Does the application provide evidence that the institution
has sufficient influence, experience, and resources to carry out the proposed
interventions? Is there a substantial level of institutional support? Is
there thorough and convincing evidence and documentation of the commitment of
institution? Is the type and extent of the institutions’ resource commitment an
appropriate commitment to patient safety? Is this effort part of an ongoing
effort to improve patient safety, or is there other evidence that the
institution has a history of successful efforts in patient safety? Is
there evidence of institutional support and commitment to sustaining and
institutionalizing the safe practice intervention once the funding has been
completed?

Protections for Human
Subjects. For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials.

Privacy
and Security Protections for Patients: The resources and processes to be use to
address privacy and security issue sin the development and implementation of
the intervention will be assessed.

Inclusion of Women, Minorities, and Children. The adequacy
of plans to address the needs of both genders, racial and ethnic groups (and
subgroups), and children as appropriate for the aims of the project.
Adequacy of attention to other populations of special priority to AHRQ (see
discussion on Priority Populations in the section on Other Submission
Requirements, above, and in the section on Required Federal Citations, below.)

Resubmission
Applications. When reviewing a Resubmission
application (formerly called an amended application), the committee will
evaluate the application as now presented, taking into consideration the
responses to comments from the previous scientific review group and changes
made to the project.

Additional Review Considerations

Not Applicable

2.C. Resource
Sharing Plan(s)

Data Confidentiality

Pursuant to 42 USC 299c-3(c), information obtained in the
course of any AHRQ supported-study that identifies an individual or entity must
be treated as confidential in accordance with any explicit or implicit promises
made regarding the possible uses and disclosures of such data. There are
civil monetary penalties for violation of the confidentiality provision of the
AHRQ statute 42 USC 299c-3(d). In the Human Subjects section of the
application, applicants must describe procedures for ensuring the confidentiality
of the identifying information to be collected. The description of the
procedures should include a discussion of who will be permitted access to this
information, both raw data and machine readable files, and how personal
identifiers and other identifying or identifiable data will be restricted and
safeguarded. Identifiable patient health information collected by
grantees under this FOA will also be obtained and managed in accordance with
the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to
limit the disclosure of personally identifiable patient information by covered
entities and define when and how such information can be disclosed e.g., to
researchers. Thus, health care plans ordinarily will require either
patient authorization for disclosures of identifiable information to be made to
researchers or waivers of such authorizations obtained from an IRB or Privacy
Board (defined in the regulations), which will involve review to ensure that
identifiable health information will be appropriately safeguarded by the
investigators. The DHHS Office of Civil Rights is the enforcement body
for this regulation. Additional information about the regulations, their
implementation, and alternative methods of permissible disclosures to researchers
(limited data sets with data use agreements, de-identified data sets, data
about deceased persons, and data use to develop protocols) can be obtained
from: http://www.hhs.gov/ocr/hipaa/

The grantee should ensure that computer systems
containing confidential data have a level and scope of security that equals or
exceeds that established by the HIPAA Security Rules if applicable (see HIPAA
website in prior paragraph) and that established by the Office of Management
and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal
Automated Information Systems. The National Institute of Standards and
Technology (NIST) has published several implementation guides for this
circular. They are: An Introduction to Computer Security: The NIST Handbook;
Generally Accepted Principals and Practices for Securing Information Technology
Systems; and Guide for Developing Security Plans for Information Technology
Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/.
The applicability and intended means of applying these confidentiality and
security standards to subcontractors and vendors, if any, should be addressed
in the application.

Sharing Research Resources:

Rights
in Data

Unless otherwise provided in grant awards, AHRQ grantees
may copyright or seek patents for, as appropriate, final and interim products
and materials developed in whole or in part with AHRQ funds, including, but not
limited to, methodological tools, measures, software with documentation,
literature searches, and analyses. Such copyrights and patents are subject to
a worldwide irrevocable AHRQ license to use and permit others to use these
products and materials for government purposes. In accordance with its
legislative dissemination mandate, AHRQ purposes may include, subject to
statutory confidentiality protections, making project materials, databases, results,
and algorithms available for verification or replication by other researchers.
In addition, subject to AHRQ budget constraints, final products may be made
available to the health care community and the public by AHRQ or its agents if
such distribution would significantly increase access to a product and thereby
produce substantial or valuable public health benefits. Ordinarily, to
accomplish distribution, AHRQ publicizes research findings but relies on
grantees to publish research results in peer-reviewed journals and to market
grant-supported products. AHRQ's Office of Communications and Knowledge
Transfer (OCKT) wishes to be consulted in advance of publication in order to
coordinate announcements of new AHRQ-supported research results with other AHRQ
dissemination activities. Important legal rights and requirements
applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html).

Selection Process

Applications submitted in response to this funding
opportunity will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:

After the peer review of the application is completed, the PD/PI will be
able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding,
AHRQ will request "Just-In-Time" information from the
applicant. Just-In-Time information generally consists of information on
other support, any additional information necessary to address administrative
issues, and certification of IRB approval of the project's proposed use of
human subjects. For details, applicants may refer to the "AHRQ
Revised Policy for Institutional Review Board (IRB) Review of Human Subjects
Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

Once all administrative and programmatic issues have been resolved, a formal
notification in the form of the Notice of Award (NOA) will be generated
via email notification from the awarding component to the grantee business
official at the applicant organization. The NOA signed by the AHRQ grants
management officer is the authorizing document.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NA are at the recipient’s risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section IV.5., “Funding
Restrictions.”

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s
grants regulations at 42 CFR Part 67, Subpart A, and are subject to the
requirements of the HHS Grants Policy Statement that are applicable based on
the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

As necessary,
additional Terms and Conditions will be incorporated into the award statement.

Activities conducted under this
award that involve the collection of information e.g., conducting surveys or
requesting responses to uniform questions from nine or more persons,
establishments or other entities, are currently required by HHS to be cleared
by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). Submissions
for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees
should include the time in their proposed timelines to develop materials and
receive necessary clearances. It typically takes at least six months from date
of initial submission to AHRQ to receive clearances ,and sometimes much longer
if submissions are incomplete or the justification for the proposed data
collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until grantees receive written
notification via e-mail from AHRQ that clearance has been obtained. Detailed
information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

3. Reporting

AHRQ strongly encourages grantees to participate in bi-monthly
teleconferences to share with AHRQ and other grantees project status,
challenges encountered, and lessons learned. This will support AHRQ’s mission
and enable AHRQ to tailor its interactions with grantees to be most supportive
of individual projects and patient safety portfolio.

The annual Progress Reports must include Sections a
through f as described in the general PHS form 2590 instructions. For details regarding progress report
submission, refer to http://www.ahrq.gov/fund/noncomp.htm.
If instructions on the AHRQ website are different from the PHS form 2590
instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and
evaluative comments on both completed activities and plans for the remainder of
that year, including any changes foreseen in the future. At a minimum,
the reports will include descriptive comments on: progress to date
measured against project aims; methodological changes implemented; key
preliminary findings; significant problems and resolutions; inclusion of
priority populations; and project related publications, presentations, and
dissemination activities. AHRQ will provide the timetable for these
progress reports.

Financial Status Reports (FSRs; SF
269) are required annually by AHRQ for ALL grant programs as described in the
HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm).
This report must be submitted for each budget period no later than 90 days
after the close of the budget period. A hard copy of the report should be
submitted to the assigned grants management specialist.

A final Progress Report and Financial Status Report are
required when an award ends. For further details regarding grant closeout
requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section
VII. Agency Contacts

We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas: scientific/research
(program), peer review, and financial or grants management issues:

1.
Scientific/Research Contact(s):

Direct your questions about general FOA issues, including information on
the inclusion of priority populations to:

Women and members of minority groups are included in all
AHRQ-supported research projects involving human subjects, unless a clear and
compelling rationale and justification are provided that inclusion is
inappropriate, e.g., because of the lack of connection between the study and
the health of women or particular minorities.

Investigators may obtain copies from the above sources or
from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html.
AHRQ Program staff may also provide additional information concerning
these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that
applications and proposals involving human subjects research must be evaluated
in accordance with those regulations, with reference to the risks to the
subjects, the adequacy of protection against these risks, the potential
benefits of the research to the subjects and others, and the importance of the
knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

The Department of Health and Human Services (DHHS)
"Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 which governs the protection of individually
identifiable health information. It is administered and enforced by the
DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools that may be used to determine whether a researcher is a staff
member of a covered entity. Compliance with the Privacy Rule for those
classified under the Rule as "covered entities" is mandatory.
Decisions about applicability and implementation of the Privacy Rule
reside with covered entities. Project Officers will assist grantees in
resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

The OMB Circular A-110 provides access to certain
research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation or
administrative order) may be accessed through FOIA. If no Federal action is
taken having the force and effect of law in reliance upon an AHRQ-supported
research project, the underlying data are not subject to this disclosure
requirement. Furthermore, even if a Federal regulatory action is taken in
reliance on AHRQ-supported research data under FOIA, disclosure of confidential
identifiable data from such study is statutorily protected under 42 USC
299c-3(c), and thus is exempted from disclosure under "the (b)(3)
exemption” in FOIA, 5 USC 552(b)(3). It is important for applicants to
understand the scope of this requirement and its limited potential impact on
data collected with AHRQ support. Proprietary data might also be exempted
from FOIA disclosure requirements under "the (b)(4) exemption", 5 USC
552(b)(4) for example, if it constitutes trade secrets or commercial
information. NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential
identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this
FOA in a public archive, which can provide protections for the data (e.g., as
required by confidentiality provisions of the statute applicable to
AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of
non-identifiable data for an indefinite period of time, they may. The application
should include a description of any archiving plan in the study design and
include information about this in the budget justification section of the
application. In addition, applicants should consider how to structure informed
consent statements or other human subject protection procedures to permit or
restrict disclosures of identifiable data, as warranted.

Healthy People 2010:

The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting health improvement
priorities for the United States. AHRQ encourages applicants to submit grant
applications with relevance to the specific objectives of this initiative.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372. Awards are made
under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in
accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes
and regulations. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the Public Health Service mission to protect and advance the physical and
mental health of the American people.